CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K112373
Device Name CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
Applicant
INNOVA VISION INC.
2904 n. boldt drive
flagstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
INNOVA VISION INC.
2904 n. boldt drive
flagstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 08/17/2011
Decision Date 08/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No